Project: LyophilizeD fecal micrObiome traNsfer for primAry closTridioides difficilE infection (DONATE study): a multicenter randomized controlled trial

Acronym DONATE (Reference Number: JPIAMR2022-020)
Duration 15/02/2023 - 14/02/2026
Project Topic Primary Clostridioides difficile infection (pCDI) carries high recurrence and mortality rates and is globally spread. pCDI is often a consequence of exposure to antibiotics, disrupting the healthy intestinal microbiota composition. Not surprisingly, in this antibiotic-associated infection, failure of the standard antibiotic treatment is high. Frozen fecal microbiota transplantation (FMT), the introduction of the microbial community from a healthy donor, has been shown to be safe and highly effective in cases of recurrent CDI, reaching >90% cumulative success rate. Importantly, FMT has shown potential for eradication of other multidrug resistant organisms (MDRO) carriage. The use of FMT for pCDI, has been tested in small studies, showing promising results. The use of frozen FMT is hampered by storage needs which limit accessibility and spread. We have developed a lyophilized FMT product (Lyo-FMT - a dry compound that does not need freezing) that retains viability, prolongs the shelf time of the product and improves patient acceptance. In a randomized controlled multicenter trial, we aim to assess the efficacy of Lyo-FMT for pCDI in comparison to standard antibiotic therapy. This easy-to-administer product will restore the microbial community, fight the infective agent and reduce the overall antibiotic-resistant gene burden. This, in turn, will lower the recurrence rate and decrease carriage of other MDRO, coupled with a reduction in antibiotic use. Data on microbial shifts during treatment will shed light on our understanding of the pathophysiology of the disease.
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Call 2nd JPIAMR-ACTION Joint Call 2022

Project partner

Number Name Role Country
1 Rambam Health Care Campus Coordinator Israel
2 European Institute of Oncology Partner Italy
3 University of Alberta Partner Canada
4 Imperial College London Partner United Kingdom
5 University of Debrecen Partner Hungary
6 Lithuanian University of Health Sciences Partner Lithuania
7 Fondazione Policlinico Universitario “A. Gemelli” IRCCS Partner Italy